MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilation.During the procedure, the balloon ruptured after the first inflation at 14 atmospheres for 10 seconds.The device was removed without any problem, and the procedure was completed with another of different device.There were no patient complications reported, and there were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilation.During the procedure, the balloon ruptured after the first inflation at 14 atmospheres for 10 seconds.The device was removed without any problem, and the procedure was completed with another of different device.There were no patient complications reported, and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual inspection revealed no damage.Microscopic examination identified a longitudinal tear in the balloon, located approximately 8 mm from the tip, measuring about 20 mm in length.No other damage or irregularities were observed upon inspection of the remaining components of the device.Product analysis confirmed the presence of a longitudinal tear in the balloon.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21689595
• Report Number: 2124215-2025-17935
• Device Sequence Number: 9419729
• Product Code: DQY
• UDI-Device Identifier: 08714729757146
• UDI-Public: (01)08714729757146(17)270823(10)34698594
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0034698594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - JUPITER FC, NS TAPERED 15.; GUIDEWIRE - JUPITER FC, NS TAPERED 15.; INTRODUCER SHEATH - LT-FA PARENT.; INTRODUCER SHEATH - LT-FA PARENT.; MICRO CATHETER - PROMINENT ADVANCE NEO.; MICRO CATHETER - PROMINENT ADVANCE NEO.; STENT - EPIC 10-60, 10-80, 10-40, 8-40.; STENT - EPIC 10-60, 10-80, 10-40, 8-40.
• Patient Sex: Unknown